Expandable support device and method of use

ABSTRACT

An expandable support device for tissue repair is disclosed. The device can be used to repair hard or soft tissue, such as bone. The expandable support device can have interconnected struts. A method of repairing tissue is also disclosed. The expandable support device can be inserted into a damaged bone and radial expanded. The radial expansion of the expandable support device struts can cause the struts to cut mechanically support and/or the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT InternationalApplication No. PCT/US2007/067967, filed May 1, 2007, which claims thebenefit of U.S. Provisional Application No. 60/796,915, filed May 1,2006, which are herein incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to devices for providing support for biologicaltissue, for example to repair spinal compression fractures, and methodsof using the same.

BRIEF SUMMARY OF THE INVENTION

An expandable support device for performing completely or partiallyimplantable spinal repair is disclosed. The device has a first strut anda second strut attached to, and/or integral with, the first strut. Thefirst strut is substantially deformable. The second strut can besubstantially inflexible.

The device can be configured to expand in a radial direction duringdeployment in a bone. The device can be configured to contract in alongitudinal direction during deployment in a bone.

An expandable support device for repairing damaged bone is disclosed.The expandable support device can have a longitudinal axis. Theexpandable support device can have a first strut having a first strutcross-section. The expandable support device can have a second strutattached to, and/or integral with, the first strut. The first strut canbe substantially deformable. The first strut cross-section can beconfigured to encourage bone growth toward the longitudinal axis.

The expandable support device can have a bone growth material. The firststrut can have the bone growth material. The first strut can be coatedwith the bone growth material. The bone growth material cancircumferentially surround the first strut cross-section.

The first strut can have a first strut first side closer to thelongitudinal axis and a first strut second side farther from thelongitudinal axis than the first strut first side, and the bone growthmaterial can be on the first strut first side. The first strut secondside can be substantially uncoated with the bone growth material.

The first strut cross-section can have a needle tip. The first strutcross-section can have a chisel tip. The first stmt can have a threadextending radially therefrom. The first strut can have a longitudinalvane extending radially therefrom.

An apparatus for deploying and retrieving an expandable support deviceis a bone is disclosed. The apparatus can have a deployment rod. Thedeployment rod can have an expandable support device engager. Theapparatus can have a retrieval sheath translatably slidable with respectto the deployment rod. The retrieval sheath can be configured toradially compress the expandable support device.

A method of retrieving a deployed expandable support device from a boneis disclosed. The method can include holding the expandable supportdevice. The method can include translating a sheath over the expandablesupport device. Translating the sheath can include translating a rigidsheath. Holding can include holding a first end of the expandablesupport device. Translating can include radially compressing theexpandable support device. The method can include translating theexpandable support device out of the bone.

A method of deploying an expandable support device having a radius in abone is disclosed. The method can include positioning the expandablesupport device in the bone. The method can also include radiallyexpanding the expandable support device through the bone. The method canalso include creating track voids. The method can also include deployinga material into the track voids, wherein the material encourages bonegrowth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a variation of the expandable supportdevice in a radially expanded configuration.

FIG. 2 is a side view of a variation of the expandable support device ina radially compressed configuration.

FIG. 3 is a rear view of the variation of the expandable support deviceof FIG. 2 in a radially compressed configuration.

FIG. 4 is a perspective view of the variation of the expandable supportdevice of FIG. 2 in a radially compressed configuration.

FIG. 5 is a close-up view of section AA of FIG. 2.

FIG. 6 is a close-up view of section AB of FIG. 2.

FIG. 7 illustrates a variation of the expandable support device in aradially contracted configuration.

FIG. 8 illustrates a variation of a cell of the expandable supportdevice of FIG. 7.

FIG. 9 illustrates a variation of the expandable support device in aradially expanded configuration.

FIG. 10 illustrates a variation of a cell of the expandable supportdevice of FIG. 9.

FIGS. 11-13 illustrate cross section B-B of various variations of theexpandable support device.

FIG. 14 illustrates cross-section C-C of the variation of the expandablesupport device in FIG. 13.

FIG. 15 is a side view of a variation of the distal attachment element.

FIG. 16 is a front view of a variation of the distal attachment element.

FIG. 17 illustrates a variation of cross-section AC-AC of FIG. 15.

FIG. 18 is a perspective view of a variation of cross-section AC-AC ofFIG. 15.

FIG. 19 is a side view of a variation of the proximal attachmentelement.

FIG. 20 is a rear view of a variation of the proximal attachmentelement.

FIG. 21 illustrates a variation of cross-section AD-AD of FIG. 19.

FIG. 22 is a perspective view of a variation of cross-section AD-AD ofFIG. 19.

FIGS. 23 through 38 illustrate various variations of section A-A of FIG.9.

FIG. 39 illustrates various methods for deploying the expandable supportdevice.

FIG. 40 illustrates a variation of a method of deploying the expandablesupport device with a deployment tool.

FIG. 41 illustrates the variation of FIG. 40 with the deployment tool ina partially disassembled configuration.

FIGS. 42 and 43 illustrate cross-section D-D of a variation of a methodfor radially expanding the expandable support device of FIG. 40.

FIGS. 44 through 46 illustrate a variation of the method of retrievingthe expandable support device.

FIG. 47 illustrates a variation of the deployment tool with theexpandable support device removed from the vertebra.

FIGS. 40, 41, and 44 through 47 illustrate the vertebra with a partialventral sagittal cut-away for illustrative purposes.

FIGS. 48 through 52 illustrate longitudinal cross-sectional views(similar to sectional view D-D) of a variation for the deployment andrecovery of a variation of the expandable support device.

FIG. 53 illustrates a variation of the expandable support device loadedon a variation of the deployment tool.

FIG. 54 illustrate cross-sections E-E and F-F of the deployment rod andexpandable support device, respectively, of FIG. 53 in aligned unlockedconfigurations.

FIG. 55 illustrate cross-sections E-E and F-F of the deployment rod andexpandable support device, respectively, of FIG. 53 in aligned lockedconfigurations.

FIGS. 56 and 57 illustrate variations of explants of the expandablesupport device with bone.

FIG. 58 is a close-up view of section H of FIG. 56.

FIGS. 59 through 61 illustrate various variations of cross-section G-Gof FIG. 57.

FIGS. 1, 40, 51, 45, 47, 56 and 57, are shown with exemplary lengthscales labeled in 10 mm increments and tabbed in ½ mm and 1 mmincrements.

Dimensions shown in FIGS. 15, 16, 17, 19 and 21 are merely examples. Alldimensions can be from about 25% to about 400% of the dimensions shownin the figures, more narrowly from about 75% to about 125% of thedimensions shown in the figures.

DETAILED DESCRIPTION

FIG. 1 illustrates an expandable support device 2 in a radially expandedand longitudinally contracted configuration. The expandable supportdevice 2 can be configured to be deployed in a treatment site, such as abone, to provide mechanical support, for example to treat compression orother fractures or other structural bone failures. The expandablesupport device 2 can have a radially contracted and longitudinallyexpanded configuration, for example before deployment into a treatmentsite. The expandable support device 2 can have a radially expanded andlongitudinally contracted configuration, for example after deploymentinto the treatment site.

The expandable support device 2 can have a longitudinal axis 4. Theexpandable support device 2 can have a distal port 6 at a longitudinallydistal end and a proximal port 8 at a longitudinally proximal end. Theexpandable support device 2 can have a device radial side 10. The deviceside 10 can be substantially the surface defined by the cells 12 andpores 14, and for example, can exclude the proximal port 8 and thedistal port 6.

The expandable support device 2 can have a number of struts 16 connectedat joints 18. The struts 16 can be rigid and/or flexible. The struts 16can be deformable and/or resilient. The joints 18 can be rigid and/orflexible. The joints 18 can be deformable and/or resilient.

The struts 16 and joints 18 can form enclosed shapes, such as cells 12.The cell 12 can dynamically act as a four-bar system (e.g., if the cellhas four struts), five-bar system (e.g., if the cell has five struts),or another closed dynamic system correlating with the number of struts16 and joints 18 of the cell.

The interior area of each cell can be a pore 14. The pores 14 can beopen to the radial center of the expandable support device 2. The pores14 can be substantially unobstructed. The pores 14 can encourage tissue(e.g., bone) growth toward the lumen or longitudinal channel of theexpandable support device 2.

The device side can have a device side area 10. The radially (e.g., withrespect to the longitudinal axis) external area joints 18 and struts 16can be a solid surface area. The radially (e.g., with respect to thelongitudinal axis) external area of the pores 14 can be a pore area. Theratio of the pore area to the device side area can be a pore ratio. Withthe expandable support device 2 in a radially expanded configuration,the pore ratio can be from about 20% to about 99%, more narrowly fromabout 50% to about 98%, yet more narrowly from about 75% to about 95%,for example about 80% or about 85% or about 90%.

Additional exemplary variations, features, elements and methods of useof the expandable support device and tools for deploying the expandablesupport device are described in PCT Patent Application Ser. Nos.PCT/US05/034115 filed 21 Sep. 2005; PCT/US05/034742 filed 27 Sep. 2005;PCT/US05/034728 filed 27 Sep. 2005; PCT/US2005/037126 filed 12 Oct.2005; and U.S. Provisional Patent Application Nos. 60/675,543 filed 27Apr. 2005; 60/741,201 filed 1 Dec. 2005; 60/741,197 filed 1 Dec. 2005;60/751,882 filed 19 Dec. 2005; 60/675,512 filed 27 Apr. 2005; 60/752,180filed 19 Dec. 2005; 60/699,577 filed 14 Jul. 2005; 60/699,576 filed 14Jul. 2005; 60/754,492 filed 28 Dec. 2005; 60/751,390 filed 15 Dec. 2005;60/752,186 filed 19 Dec. 2005; 60/754,377 filed 27 Dec. 2005; 60/754,227filed 28 Dec. 2005; 60/752,185 filed 19 Dec. 2005; and 60/752,182 filed19 Dec. 2005; all of which are incorporated by reference herein in theirentireties.

FIGS. 2, 3 and 4 illustrate that a distal end of the expandable supportdevice 2 can be attached to and/or integral with a distal releasableattachment element 20. The proximal end of the expandable support device2 can be attached to and/or integral with a proximal releasableattachment element 22.

FIG. 5 illustrates that the distal releasable attachment element 20 canbe fixedly or removably attached to the expandable support device 2 atone or more attachment points 24. The attachment points 24 can be welds,press fits, adhesive, integrated elements, or combinations thereof.

FIG. 6 illustrates that the proximal releasable attachment element 22can be fixedly or removably attached to the expandable support device 2at one or more attachment points 24. The proximal releasable attachmentelement 22 can have a varying outer diameter along its length. The outerdiameter of the proximal releasable attachment element 22 act as aninterface, for example to be engaged by a deployment tool.

FIG. 7 illustrates that the expandable support device 2 can have aradially contracted configuration. The expandable support device 2 canhave a contracted diameter 26 and an expanded length 28. The expandablesupport device 2 can have a substantially cylindrical shape.

FIG. 8 illustrates that the cell 12 can have at least one longitudinalcell angle 30. The longitudinal cell angle 30 can be the angle formedbetween a first strut 32 and a second strut 34. The longitudinal cellangle 30 can face in a substantially parallel, or otherwise aligned,direction to the longitudinal axis 4.

The cell 12 can have at least one transverse cell angle 36. Thetransverse cell angle 36 can be the angle formed between the first strut32 and a third strut 38. The transverse cell angle 36 can face in asubstantially perpendicular or otherwise misaligned direction to thelongitudinal axis 4. The transverse cell angle 36 can face in asubstantially perpendicular or otherwise misaligned direction to thelongitudinal cell angle 30.

FIG. 9 illustrates that the expandable support device 2 can have aradially expanded configuration. The expandable support device 2 canhave an expanded diameter 40 and a contracted length 42. The expandeddiameter 2 can be greater than the contracted diameter 26. Thecontracted length 42 can be less than the expanded length 28. Theexpandable support device 2 can have a substantially spherical, toroidor cubical shape.

FIG. 10 illustrates that transverse cell angle 36 in the cell 12 fromthe expandable support device 2 having the radially expandedconfiguration can be smaller than the cell angle 36 in the cell from theexpandable support device 2 having the radially contractedconfiguration. The longitudinal cell angle 30 in the cell 12 from theexpandable support device 2 having the radially expanded configurationcan be larger than the cell angle 36 in the cell 12 from the expandablesupport device 2 having the radially contracted configuration.

Figure 11 illustrates that the expandable support device 2 can havereleasable attachment elements at the distal and/or proximal ends. Forexample, the expandable support device 2 can have distal device threads44 and/or proximal device threads 46. The device mid-length section 48can be bare of threads. The releasable attachment elements can becontrollably removably attached to a deployment tool and/or theremainder of the expandable support device 2.

FIG. 12 illustrates that the device threads 50 can be continuous and/orsubstantially continuous from the proximal to the distal end (i.e.,including the device mid-length section 48) of the expandable supportdevice 2.

FIGS. 13 and 14 illustrates that the releasable attachment element, suchas the proximal releasable attachment element 22, can be one or moredevice keys 52. The device keys 52 can have device key distal ends 54.The device key distal ends 54 can protrude in the distal direction and,for example can be sharpened. Device key ports 56 can be angularlybetween the device keys 52. The releasable attachment devices can bethreads, keys, tabs, luers, or combinations thereof.

FIGS. 15, 16, 17 and 18 illustrate that the distal releasable attachmentelement 20 can have an internal channel 58. The internal channel 58 canhave an internal channel diameter 59. The internal channel diameter 59can be from about 1 mm (0.4 in.) to about 3 mm (0.1 in.), for exampleabout 1.99 mm (0.0785 in.)

The distal releasable attachment element 20 can have distal devicethreads 44 (shown in FIG. 18).

The distal releasable attachment element 20 can have a sharpened distalend. The sharpened distal end can be used, for example, to push throughbone during use. The sharpened distal end can have a sharpened distalend angle 61. The sharpened distal end angle 61 can be from about 20° toabout 70°, for example about 45°.

The distal releasable attachment element 20 can have a distal releasableattachment element length 63. The distal releasable attachment elementlength 63 can be from about 13 mm (0.051 in.) to about 5 mm (0.2 in.),for example about 2.92 mm (0.115 in.).

The distal releasable attachment element 20 can have a distal releasableattachment element outer diameter 65. The distal releasable attachmentouter diameter 65 can be from about 2.5 mm (0.098 in.) to about 10 mm(0.4 in.), for example about 4.78 mm (0.188 in.).

The distal releasable attachment element 20 can have an inner chamfer67. The inner chamfer 67 can have an angle of about 45° from theadjacent sides and can have a length of about 0.2 mm (0.009 in.).

FIGS. 19, 20, 21 and 22 illustrate that the proximal releasableattachment element 22 can have the internal channel 58. The distalreleasable attachment element 20 can have distal device threads 44(shown in FIG. 18). The distal releasable attachment element 20 can havean engagable (e.g., lipped or notched) proximal end. The engagableproximal end can be configured, for example, to releasably engage adeployment tool.

FIG. 23 illustrates that the struts 16 can define a circular or ovalcross-section of the expandable support device 2 in a givencross-section A-A. The pores 14 can have pore angles 60 with respect tothe longitudinal axis 4 in cross-section, as shown. The pore angles 60can vary around the cross-section of the expandable support device 2(i.e., as the pores get closer to distal and proximal joints, the poreangles approach zero). The struts 16 can have uniform (as shown) orvarious cross-sectional configurations. The struts 16 can havesubstantially circular cross-sections, as shown in FIG. 10.

FIG. 24 illustrates that the struts 16 can form a square or rectangularcross-section of the expandable support device 2 in a givencross-section A-A. One or more of the struts 16 can have markers 62,such as radiopaque and/or echogenic markers. The markers 62 can beunique for each strut 16. For example, the markers 62 can identify thedeployment orientation, as shown (e.g., arrows pointing in the updirection for deployment, with the top strut's marker showing a toparrow; the left strut's marker showing an arrow with only a leftarrow-end; the right strut's marker showing an arrow with only a leftarrow-end; and the bottom strut's marker showing an arrow with thearrowhead near the bottom of the arrow).

FIG. 25 illustrates that the struts 16 can have substantially square orrectangular cross-sectional configurations. The struts 16 and joints 14(not shown, and understood to be substantially represented whendescribing the struts in cross-sections A-A) can have first rectilinearaxes 64. The first rectilinear axes 64 can substantially or completelyintersect the longitudinal axis 4 in a given cross-section A-A.Expandable support devices 2 that do not have circular or ovulartransverse cross-sections (i.e., the shapes defined by the struts andpores shown in cross-section A-A), such as square, rectangular,triangular transverse cross-sections, or combinations thereof, can haveone or more struts 16 with rectilinear axes 64 that do not substantiallyintersect the longitudinal axis 4 in a given cross-section A-A.

FIG. 26 illustrates that the struts 16 and joints 14 (not shown) canhave diametric or diagonal axes 66 in a given cross-section A-A. Thediametric or diagonal axes 66 can substantially or completely intersectthe longitudinal axis 4. Expandable support devices 2 that do not havecircular or ovular transverse cross-sections (i.e., the shapes definedby the struts and pores shown in cross-section A-A), such as square,rectangular, triangular transverse cross-sections, or combinationsthereof, can have one or more struts 16 with diametric or diagonal axes66 that do not substantially intersect the longitudinal axis 4 in agiven cross-section A-A. The struts 16 can have square or rectangularcross-sectional configurations.

FIG. 27 illustrates that the struts 16 and joints 14 (not shown) canhave rectangular or oval (as shown) cross-sectional configurations orother cross-sectional configurations with primary and secondary axes.The oval cross-sections can each have a major (i.e., primary) axis 68.The oval cross-sections can each have a minor (i.e., secondary) axis 70in a given cross-section A-A. The major axes 68 can substantially orcompletely intersect the longitudinal axis 4. The minor axes 70 cansubstantially or completely intersect the longitudinal axis 4.Expandable support devices 2 that do not have circular or ovulartransverse cross-sections (i.e., the shapes defined by the struts andpores shown in cross-section A-A), such as square, rectangular,triangular transverse cross-sections, or combinations thereof, can haveone or more struts 16 with major 68 and/or minor axes 70 that do notsubstantially traverse the longitudinal axis 4 in a given cross-sectionA-A.

FIG. 28 illustrates that the struts 16 and joints 14 (not shown) canhave triangular (e.g., diagonal, right, isosceles, equilateral)cross-sectional configurations. The triangular configurations can eachhave the major axis 68.

FIG. 29 illustrates that the struts 16 and joints 14 (not shown) canhave needle tips 72, for example with a triangular configurationcross-sectional configuration. The needle tip 72 can have a first needleside 74 and a second needle side 76. One or both needle sides can beconcave inward. The needle tip 72 can have a needle tip angle from about0.1° to about 30°, more narrowly from about 0.5° to about 25°, yet morenarrowly from about 2° to about 20°, for example about 5° or about 10°or about 15°.

FIG. 30 illustrates that the struts 16 and joints 14 (not shown) caneach have a first needle tip 78 pointed radially outward, and a secondneedle tip 80 pointed radially inward. The major axis 68 can be themajor axis for the first and second needle tips 78, 80.

FIG. 31 illustrates that the struts 16 and joints 14 (not shown) canhave a first tip 82 and a second tip 84 along the major axis 68. Thestruts 16 can be of nominal or otherwise substantially no thickness indirections other than the major axis 68.

FIG. 32 illustrates that the struts 16 and joints 14 (not shown) canhave a nail-like configuration. The struts 16 can have a tip 86 runningon the major axis 68. The struts 16 can have a head 88, for example, atabout a 90° angle to the tip 86 and/or to the major axis 68.

FIG. 33 illustrates that the struts 16 and joints 14 (not shown) canhave chisel tips 90. The struts 16 can have quadrilateral (e.g.,bicentric quadrilateral, cyclic quadrilateral, orthocentricquadrilateral, rational quadrilateral), parallelogram (e.g., medialparallelogram), rhombus (e.g., golden rhombus), kite, lozenge, trapezoid(e.g., isosceles trapezoid), tetrahedron cross-sectional configurationor combinations thereof.

FIG. 34 illustrates that the struts 16 and joints 14 (not shown) canhave randomly-shaped surface 92 configurations. The randomly-shapedsurface 92 configurations can have an irregular surface defined by arandom or quasi-random configuration.

FIG. 35 illustrates that the struts 16 can have a textured (e.g.,non-randomly surfaced) surface 94 configuration. For example, thetextured surface 94 configuration can have a knurled, convex or concavedimpled or bumped, transversely and/or longitudinally and/or diagonallycheckered or grooved (as shown), or brushed configuration, orcombinations thereof.

FIG. 36 illustrates that the struts 16 can each have one or more threadsand/or longitudinal vanes 96 attached to or integral therewith. Thethreads and/or vanes 96 can extend radially toward the longitudinal axis4. The threads and/or vanes 96 can have a coating or be made partiallyor completely from any material listed herein, such as cements and/orfillers and/or glues (e.g., bone morphogenic protein, morselized bone,additional examples listed infra), such as for soliciting or otherwiseencouraging bone growth. The threads and/or vanes 96 can be flexible orrigid. The threads and/or vanes 96 can be resilient and/or deformable.The threads and/or vanes 96 can be made in whole or part from abioresorbable, bioabsorbable or biodegradable material. The variousthreads and/or vanes 96 can have uniform or variable lengths.

FIG. 37 illustrates that the struts 16 can be wholly (as shown) orpartially coated and/or otherwise covered by a coating and/or matrix 98of any material listed herein. FIG. 38 illustrates that the struts 16can be coated and/or be otherwise covered by a material listed herein onthe side of the strut 16 facing the longitudinal axis 4. The side of thestrut 16 not facing the longitudinal axis 4 can have no coatingneither/nor be otherwise covered by a material other than the materialof the original non-coated/covered strut.

Any or all elements of the expandable support device 2 and/or deploymenttool and/or other devices or apparatuses described herein can be madefrom, for example, a single or multiple stainless steel alloys, nickeltitanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY®from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from CarpenterMetals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® fromMagellan Industrial Trading Company, Inc., Westport, Conn.), molybdenumalloys (e.g., molybdenum TZM alloy, for example as disclosed inInternational Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which isherein incorporated by reference in its entirety), tungsten-rheniumalloys, for example, as disclosed in International Pub. No. WO03/082363, polymers such as polyethylene teraphathalate (PET), polyester(e.g., DACRON® from E. I. Du Pont de II Nemours and Company, Wilmington,Del.), polypropylene, aromatic polyesters, such as liquid crystalpolymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultrahigh molecular weight polyethylene (i.e., extended chain, high-modulusor high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA®Fiber and SPECTRA® Guard, from Honeywell International, Inc., MorrisTownship, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, theNetherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketoneketone (PEKK) (also poly aryl ether ketone ketone), nylon,polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris,France), aliphatic polyether polyurethanes (e.g., TECOFLEX® fromThermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride(PVC), polyurethane, thermoplastic, fluorinated ethylene propylene(FEP), absorbable or resorbable polymers such as polyglycolic acid(PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lacticacid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA),polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extrudedcollagen, silicone, zinc, echogenic, radioactive, radiopaque materials,a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone) any of the other materials listed herein or combinations thereofExamples of radiopaque materials are barium sulfate, zinc oxide,titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

Any or all elements of the expandable support device 2 and/or deploymenttool and/or other devices or apparatuses described herein, can be, have,and/or be completely or partially coated with agents and/or a matrix amatrix for cell ingrowth or used with a fabric, for example a covering(not shown) that acts as a matrix for cell ingrowth. The matrix and/orfabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pontde Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE,nylon, extruded collagen, silicone or combinations thereof.

The expandable support device 2 and/or deployment tool and/or elementsof the expandable support device 2 and/or elements of the deploymenttool and/or other devices or apparatuses described herein and/or thefabric can be filled, coated, layered and/or otherwise made with and/orfrom cements, fillers, glues, and/or an agent delivery matrix known toone having ordinary skill in the art and/or a therapeutic and/ordiagnostic agent. Any of these cements and/or fillers and/or glues canbe osteogenic and osteoinductive growth factors.

Examples of such cements and/or fillers includes bone chips,demineralized bone matrix (DBM), calcium sulfate, corallinehydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,polymethyl methacrylate (PMMA), biodegradable ceramics, bioactiveglasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs)such as recombinant human bone morphogenetic proteins (rhBMPs), othermaterials described herein, or combinations thereof.

The agents within these matrices can include any agent disclosed hereinor combinations thereof, including radioactive materials; radiopaquematerials; cytogenic agents; cytotoxic agents; cytostatic agents;thrombogenic agents, for example polyurethane, cellulose acetate polymermixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious,hydrophilic materials; phosphor cholene; anti-inflammatory agents, forexample non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer A G, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2inHypoxic Vascular Endothelium, J. Biological Chemistry 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties.

METHOD OF USE

FIG. 39 illustrates that a first deployment tool 100 can enter throughthe subject's back. The first deployment tool 100 can enter through afirst incision 102 in skin 104 on the posterior side of the subject nearthe vertebral column 106. The first deployment tool 100 can betranslated, as shown by arrow 108, to position a first expandablesupport device 110 into a first damage site 112. The first access port114 can be on the posterior side of the vertebra 116.

A second deployment tool 118 can enter through a second incision 120 (asshown) in the skin 104 on the posterior or the first incision 102. Thesecond deployment tool 118 can be translated through muscle (not shown),around nerves 122, and anterior of the vertebral column 106. The seconddeployment tool 118 can be steerable. The second deployment tool 118 canbe steered, as shown by arrow 124, to align the distal tip of the secondexpandable support device 126 with a second access port 128 on a seconddamage site 130. The second access port 128 can face anteriorly. Thesecond deployment tool 118 can translate, as shown by arrow 132, toposition the second expandable support device 126 in the second damagesite 130.

The vertebra 116 can have multiple damage sites 112, 130 and expandablesupport devices 2 deployed therein. The expandable support devices 2 canbe deployed from the anterior, posterior, both lateral, superior,inferior, any angle, or combinations of the directions thereof.

As shown in applications incorporated by reference herein, theexpandable support device 2 can be inserted in the vertebra 116 in aradially contracted configuration. The expandable support device 2 canthen be radially expanded.

FIG. 40 illustrates the expandable support device 2 in a partiallydeployed, radially expanded configuration in the vertebra 116. Theexpandable support device 2 can be removably attached to the deploymenttool 134. The deployment tool 134 can have a deployment rod sheath 136,as shown. The expandable support device 2 can be attached to adeployment rod and/or the deployment rod sheath 136.

FIG. 41 illustrates FIG. 40 with the deployment tool 134 partiallydisassembled for illustrative purposes. The deployment tool 134 can havea recovery sheath 138. The recovery sheath 138 can be slidably attachedover the deployment rod and/or the deployment rod sheath 136. Therecovery sheath 138 can be hollow cylinder. The recovery sheath 138 canbe translatably controlled by the deployment tool 134. The deploymentrod sheath 136 can be slidably or fixedly attached to the deployment rodand/or the remainder of the deployment tool 134.

FIG. 42 illustrates that a deployment tool 134 can have a distal toolhead 140 at the distal end of a distal tool shaft 142. The distal toolshaft 142 can be removably attached to the distal end of the expandablesupport device 2 (e.g. interference fit and/or threadably attached). Thedeployment tool 134 can have an engagement element 144 that can beremovably attached (e.g., threadably attached and/or interference fit)to the proximal end of the expandable support device 2. For example, oneor more struts 16 at the proximal end of the expandable support device 2can be releasably compressed between the engagement element 144 and aproximal anvil 146 that can be attached to or integral with thedeployment rod 148.

The distal tool shaft 142 can be translated proximally, as shown byarrow 150. The distal tool head 140 and the proximal anvil 146 canlongitudinally compress, as shown by arrow 152, the expandable supportdevice 2. The expandable support device 2 can then radially expand, asshown by arrow 154.

FIG. 43 illustrates that the distal tool head 140 can be removablyattached (e.g., unscrewable, or unlockable—as a key, or retractable(e.g., rotatably, or otherwise compressably or condensably)) attached tothe distal tool shaft 142. The distal tool head 140 can be retracted andthe distal tool shaft 142 can be translated out of the expandablesupport device, as shown by arrow 150.

FIGS. 44 and 45 illustrate that the expandable support device 2 can bein a radially expanded configuration in the vertebra. The expandablesupport device 2 can be attached to the deployment tool 134 (e.g., neverreleased during deployment or released and re-attached/re-engaged). Theexpandable support device 2 can be in an incorrect location, improperlyradially expanded, or otherwise desirous of being removed, repositioned,or otherwise redeployed. The recovery sheath 138 can be translated, asshown by arrow 156, toward and onto the expandable support device 2. Theexpandable support device 2, substantially other than the recoverysheath 138, can be substantially stationary with respect to theexpandable support device 2. The recovery sheath 138 can begin to radialcompress, as shown by arrows 158, the expandable support device 2.

FIG. 46 illustrates that the recovery sheath 138 can be additionallytranslated, as shown by arrow 156, over the expandable support device 2.The expandable support device 2 can radially contract, as shown byarrows 158, for example into a substantially radially contractedconfiguration. The deployment tool 134 can then by translated, as shownby arrow 160, away from the vertebra 116. The deployment tool 134 canreposition the expandable support device 2 and retract the recoverysheath 138, and for example radially expand the expandable supportdevice 2 in the vertebra 116 (e.g., with or without removing theexpandable support device from the vertebra).

FIG. 47 illustrates that the deployment tool 134 can completely removethe expandable support device 2 from the vertebra 116. The same or adifferent expandable support device 2 can then be deployed into thevertebra 116.

FIG. 48 illustrates that the expandable support device 2 can bereleasably attached to the deployment tool 134. The deployment tool 134can have the deployment rod 148 extending from the deployment rod sheath136. The deployment tool 148 can have distal rod threads 162. The distalrod threads 162 can be releasably (e.g., rotatably) attached to thedistal device threads 44. The deployment rod 148 can have proximal rodthreads 164 between the distal rod threads 162 and the proximal devicethreads 46. The deployment tool 134 can have a deployment rod sheath136. The deployment rod sheath 136 can abut, interference fit orotherwise attach to the proximal end of the expandable support device 2.

FIG. 49 illustrates that the deployment rod 148 can be forciblyproximally translated, as shown by arrow 166. The expandable supportdevice 2 can then be longitudinally compressed, as shown by arrow 168,between the distal device threads 44 and the deployment rod sheath 136and/or other proximal attachment device (not shown). The expandablesupport device 2 can radially expand, as shown by arrows 170, forexample due to the longitudinal compression 152.

FIG. 50 illustrates that, with the expandable support device 2 in aradially expanded configuration, the deployment rod 148 can beproximally translated, as shown by arrow 166. The translation of thedeployment rod can, for example, be due to rotation of the deploymentrod 148, as shown by arrow 172, and the threading of distal rod threads162 through the distal device threads 44.

The proximal rod threads 164 can thread into the proximal device threads46. If the placement and configuration of the expandable support device2 is satisfactory, the proximal rod threads 164 can be rotatably removedfrom the proximal device threads 46. The deployment device can then beremoved entirely. If the placement and configuration of the expandablesupport device 2 is not satisfactory, the expandable support device 2can be radially contracted and removed from the treatment site, asdescribed infra.

FIG. 51 illustrates that the recovery sheath 138 can be translated, asshown by arrow 156, toward the expandable support device 2, and/or theexpandable support device 2 can be translated (e.g., via translation ofthe attached deployment rod 148) toward the recovery sheath 138.

FIG. 52 illustrates that the recovery sheath 138 can be translated ontothe expandable support device 2, as shown by arrow 171, and/or theexpandable support device 2 (e.g., via translation of the attacheddeployment rod 148) can be translated, as shown by arrow 173, into therecovery sheath 138 and/or the expandable support device 2 can betranslated toward the recovery sheath 138. As the expandable supportdevice 2 is translated into the recovery sheath 138, the expandablesupport device 2 can be radially contracted, as shown by arrows 174.When the expandable support device 2 is sufficiently radially contracted174 and/or in the recovery sheath 138, the deployment tool 134 and theexpandable support device 2 can be removed from the treatment site.

FIGS. 53 and 54 illustrates that the deployment tool 134 can have adeployment rod key 176. The deployment rod key 176 can be configured tointerference fit against the device key 52 when the expandable supportdevice 2 and the deployment tool 134 are in a locked configuration, asshown in FIG. 54. As shown in FIG. 55, when the deployment rod 148 isrotated into an unlocked configuration, as shown by arrow, thedeployment rod key 176 can be configured to translate through the devicekey port 56, and the device key 52 can translate through the deploymentrod key port 178.

After being radially expanded, the expandable deployment device 2 can bedetached from the deployment tool 134 by turning the deployment rod 148to the unlocked configuration, and then proximally translating thedeployment rod 148. The expandable support device 2 can be radiallycontracted into the recovery sheath 138 by turning the deployment rod148 to the locked configuration, and then distally translating therecovery sheath 138 while holding and/or proximally translating thedeployment rod 148.

FIGS. 56 though 58 illustrate an expandable support device 2 explantedfrom a bone 180 can have bone substantially surrounding the struts 16.The bone 180 can pass through the pores 14. The struts 16 and joints 18can be forced through the bone 180 during deployment of the expandablesupport device 2 in the bone 180. The bone 180 can grow around thestruts 16 and joints 18 after deployment.

FIG. 59 illustrates the struts 16 can deploy through the bone 180. Whenthe struts 16 expand (e.g., during radial expansion of the expandablesupport device 170), the struts 16 can create voids or struts tracks182. The struts 16 can have a wide enough dimension transverse to thedirection of radial expansion that the strut tracks 182 can be largeenough to access and fill partially or completely with any material(e.g., BMP, bone cement, morselized bone, bone growth matrix). Thestruck tracks 182 can also be filled partially or completely with thethreads or longitudinal vanes 96.

FIG. 60 illustrates that the strut 16 can be configured to leave a largeor small strut track 182 during radial expansion of the expandablesupport device 170. The width of the track 182 can correspond to thestrut width. The struts 16 can have a narrow dimension transverse to thedirection of radial expansion. For example, the strut 16 can have adiamond-shaped cross-section with a longer dimension in the radialdimension than the angular dimension (i.e., the strut dimensiontransverse to the radial dimension). The visco-elastic nature of bone(e.g., cancellous bone and/or cortical bone) can cause the bone toback-fill the tracks 182 as shown in FIG. 60.

FIG. 61 illustrates that the strut 16 can be configured to leave anominal or no strut track during radial expansion of the expandablesupport device 170. The struts 16 can have a nominal or otherwisesubstantially no thickness in the angular dimension (i.e., the strutdimension transverse to the radial dimension).

The expandable support device 2 can also be used for various othermedical and non-medical applications: to immobilize and/or stabilizeorthopedic trauma, hip fractures and other trauma, clavicle fracturesand other trauma, small bones (e.g., carpals, tarsals, talus, otherhand, feet and ankle bones) fractures and other trauma, other long bonerepair (e.g., internal bone splinting), spinal fusion, use as anintermedullary canal implant to anchor an artificial joint, use as abone anchor for a tendon repair or ligament implant (e.g., for anteriorcruciate ligament repair or replacement), or combinations thereof.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The above-described configurations,elements or complete assemblies and methods and their elements forcarrying out the invention, and variations of aspects of the inventioncan be combined and modified with each other in any combination. Alldevices, apparatuses, systems, and methods described herein can be usedfor medical (e.g., diagnostic, therapeutic or rehabilitative) ornon-medical purposes.

1. An expandable support device for repairing damaged bone, theexpandable support device having a longitudinal axis, and comprising: afirst terminal end comprising a radially external first attachmentconfiguration; a second terminal end comprising a radially externalsecond attachment configuration, and a radially internal attachmentconfiguration; a first strut having a first strut cross-section; asecond strut connected to the first strut, wherein the first strut issubstantially deformable; and wherein the first strut cross-section isconfigured to encourage bone growth toward the longitudinal axis.
 2. Thedevice of claim 1, further comprising a bone growth material.
 3. Thedevice of claim 2, wherein the first strut comprises the bone growthmaterial.
 4. The device of claim 2, wherein the first strut is coatedwith the bone growth material.
 5. The device of claim 4, wherein thebone growth material circumferentially surrounds the first strutcross-section.
 6. The device of claim 4, wherein the first strut has afirst strut first side closer to the longitudinal axis and a first strutsecond side farther from the longitudinal axis than the first strutfirst side, and wherein the bone growth material is on the first strutfirst side.
 7. The device of claim 6, wherein the first strut secondside is not substantially coated with the bone growth material.
 8. Thedevice of claim 1, wherein the first strut cross-section comprises aneedle tip.
 9. The device of Claim 1, wherein the first strutcross-section comprises a chisel tip.
 10. The device of claim 1, whereinthe first strut comprises a thread.
 11. The device of claim 1, whereinthe first strut comprises a longitudinal vane.
 12. The device of claim1, further comprising: a detachable deployment rod comprising anexpandable support device engager; and a detachable retrieval sheathtranslatably slidable with respect to the deployment rod, wherein theretrieval sheath is configured to radially.compress the expandablesupport device.
 13. The device of claim 1, wherein the first strutcross-section is small enough to allow the bone to substantiallyback-fill track voids created by radial expansion of the firstcross-section.
 14. The device of claim 13, wherein the second strutcross-section is small enough to allow the bone to substantiallyback-fill track voids created by radial expansion of the secondcross-section.
 15. A method of deploying an expandable support devicehaving a radius in a bone comprising: positioning the expandable supportdevice in the bone; radially expanding the expandable support devicethrough the bone; and creating track voids through the bone.
 16. Themethod of claim 15, further comprising deploying a material into thetrack voids, wherein the material encourages bone growth.
 17. The methodof claim 15, wherein radially expanding the expandable support devicecomprises creating track voids.
 18. A method of retrieving a deployedexpandable support device from a bone comprising: holding the expandablesupport device; and translating a sheath over the expandable supportdevice.
 19. The method of claim 18, wherein translating a sheathcomprises translating a rigid sheath, and wherein holding comprisesholding a first end of the expandable support device, and whereintranslating further comprises radially compressing the expandablesupport device.
 20. The method of claim 18, further comprisingtranslating the expandable support device out of the bone.